Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

This study is comparing two treatments for early-stage non-small cell lung cancer: Stereotactic Radiotherapy (a type of radiation therapy given in 3-5 sessions) and Anatomic Pulmonary Resection (surgery to remove part of the lung). Doctors want to see if one treatment leads to better overall survival (how long people live). You may be able to join if you are 18 or older and have a diagnosis of stage I non-small cell lung cancer, with a tumor 5 cm or smaller. The study aims to enroll 670 participants. The current recruitment status is unclear.

Study design
This is an interventional study comparing two treatments for lung cancer. It plans to enroll 670 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured from the date you join the study through its completion, up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02984761

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~670 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Stereotactic RadiotherapyAnatomic Pulmonary Resection

At a glance

Recruiting sites
14 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over From date of randomization through study completion, up to 10 years
Lung Neoplasm
17 sites across 14 states
California2
Florida2
Pennsylvania2
Illinois1
Indiana1
Maryland1
Massachusetts1
Michigan1
  • Drew Moghanaki, MD MPH · STUDY_CHAIR · VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • David H Harpole, MD · STUDY_CHAIR · Durham VA Medical Center, Durham, NC

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Eligibility criteria

Inclusion

Age 18 or older
Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\]
Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
Karnofsky performance status greater than or equal to 70
Participant has willingness and ability to provided informed consent for participation
Biopsy proven non-small cell lung cancer
Participant's case reviewed at multidisciplinary conference
Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).
Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)
Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT
Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.
Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.
Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
Participant willingness to be randomized

Exclusion

Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
Pathological confirmation of nodal or distant metastasis
Prior history of lung cancer, not including current lesion
Prior history of thoracic surgery or lung or esophageal cancer. \[prior cardiac surgery acceptable\]
Prior history of radiotherapy to the thorax
Prior history of invasive state I-III malignancy treated with surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy in the past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (less than or equal to 1 cm), follicular lymphoma, or chronic lymphocytic leukemia.
Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
Ever diagnosed with stage IV metastatic cancer of any type
History of scleroderma
Positive Pregnancy test (for women \<61 years of age or without prior hysterectomy)
Pathological confirmation of nodal or metastatic disease
  • Overall SurvivalFrom date of randomization through study completion, up to 10 years

    Survival estimates will include death from any cause.